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Dexmedetomidine 0.004 MG/ML [Precedex] for Obstetric Anesthesia

Phase 3

Waitlist Available

Research Sponsored by St. Justine's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

Study Summary

This trial is a prospective, randomized, controlled, double-blind, single-center pilot study that will assess the feasibility of a larger study on the use of dexmedetomidine for spinal anesthesia during elective cesarean section.

Eligible Conditions

Obstetric Anesthesia
Non-Narcotic Analgesics
Spinal Anesthesia
Opioid Analgesics
Obstetric Analgesia
Pain relief
Dexmedetomidine

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase 3 study feasability

Secondary outcome measures

Nausea

Opioids consumption

Pain level

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Test groupExperimental Treatment1 Intervention

Monitoring will be installed upon arrival.Metoclopramide 10 mg IV and Dexamethasone 4 mg will be given for nausea-prophylaxis. Patients may be given ondansetron 4 mg as rescue. Cefazoline 2G or clindamycin 900 mg will be given.A sterile spinal technique will be performed with a 25G Whitacre. Bupivacaine 12 mg (1.6 ml) will be drawn and given, along with dexmedetomidine 3 mcg (0.75 mL) previously blindly prepared for a total of 2.35 ml.Adequate blood pressure will be maintained with phenylephrine infusion or ephedrine IV. Glycopyrrolate 0.2 mg may be given for bradycardia.Once an adequate sensory block is obtained, the obstetrics team can perform the surgery.The patient will receive a dose of ketorolac 30 mg IV before leaving the PACU and then Naproxen 500 mg PO every 12 hours.She will receive acetaminophen 975 mg PO every 6 hours and hydromorphone 2-4 mg PO every 3 hours prn. Patients will also have access to a protocol for treatment of nausea and pruritus.

Group II: Control groupActive Control1 Intervention

Monitoring will be installed upon arrival.Metoclopramide 10 mg IV and Dexamethasone 4 mg will be given for nausea-prophylaxis. Patients may be given ondansetron 4 mg as rescue. Cefazoline 2G or clindamycin 900 mg will be given.A sterile spinal technique will be performed with a 25G Whitacre. Bupivacaine 12 mg (1.6 ml) will be drawn and given, along with morphine 100 mcg, fentanyl 15 mcg and normal saline 0.25 ml previously blindly prepared for a total of 2.35 ml.Adequate blood pressure will be maintained with phenylephrine infusion or ephedrine IV. Glycopyrrolate 0.2 mg may be given for bradycardia.Once an adequate sensory block is obtained, the obstetrics team can perform the surgery.The patient will receive a dose of ketorolac 30 mg IV before leaving the PACU and then Naproxen 500 mg PO every 12 hours.She will receive acetaminophen 975 mg PO every 6 hours and hydromorphone 2-4 mg PO every 3 hours prn. Patients will also have access to a protocol for treatment of nausea and pruritus.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexmedetomidine 0.004 MG/ML [Precedex]

2022

Completed Phase 3

~50

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

St. Justine's HospitalLead Sponsor

196 Previous Clinical Trials

78,987 Total Patients Enrolled

Christina LamontagneStudy DirectorSte-Justine's Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people still being recruited to participate in this research project?

"That is correct, the listing on clinicaltrials.gov does show that this study needs more patients. This trial was posted on March 15th, 2022 and updated October 28th, 2022. The research team is looking for 52 individuals total, at a single location."

Answered by AI

Do we have a history of research on the effects of Dexmedetomidine 0.004 MG/ML [Precedex]?

"As of now, there are 118 active clinical trials for Dexmedetomidine 0.004 MG/ML [Precedex] with 25 in Phase 3. Many of these medical studies are based in Karachi, Sindh; however, there are 222 total locations running these kinds of trials."

Answered by AI

Is there a high potential for Dexmedetomidine 0.004 MG/ML [Precedex] to cause harm?

"Dexmedetomidine 0.004 MG/ML [Precedex] received a score of 3 because there is efficacy data from Phase 3 trials as well as multiple rounds of safety data."

Answered by AI

Why is Dexmedetomidine 0.004 MG/ML [Precedex] given to patients so often?

"Dexmedetomidine 0.004 MG/ML [Precedex] is most commonly used as treatment for disease. It can also be administered to treat multiple other conditions like ventilations, mechanical, cyclic vomiting syndrome, intubations."

Answered by AI

How many people are allowed to enroll in this clinical trial?

"That is correct, the online information indicates that this study is still recruiting patients. The trial was first posted on March 15th, 2022 and received its last update on October 28th, 2022. Currently, they are looking for 52 participants from 1 site."

Answered by AI

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